Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

OMB Meeting 4-11-2019 Pre-read Materials

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a) 3M Molecular Detection System (instrument), power supply, cord, USB cable and

software

b) 3M Molecular Detection Speed Loader Tray

c) 3M Molecular Detection Chill Block Tray and Chill block insert d) 3M Molecular Detection Heat Block Insert e) 3M Molecular Detection Cap/Decap Tool [Reagent] f) 3M Molecular Detection Cap/Decap Tool [Lysis]

g) Empty lysis tube rack h) Empty reagent tube rack

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i) Dey-Engley (D/E) Neutralizing Broth

j) Demi-Fraser broth (with additional of ferric ammonium citrate)

Additional media

a) Oxford Agar (OX)b) Sheep blood agar (SBA)

b) Fraser broth (FB) c) Sheep blood agar (SBA) e) Ottaviani Agosti Agar (OAA) f) Trypticase soy agar (TSA) d) PALCAM agar

g) Trypticase soy agar with 0.6% Yeast extract (TSA/YE)

h) De Man, Rogosa and Sharpe (MRS) i) Modified Oxford agar (MOX) j) Brain heart infusion (BHI) broth k) Horse blood overlay (HBO) l) Buffered Listeria enrichment broth (BLEB)

Apparatus

a) Pipettes . – capable of 20µL

b) Multi-channel pipette . – capable of 20µL c) Sterile pipette tips. – capable of 20µL d) Stomacher® . – Seward or equivalent e) Filter Stomacher® bags . - Seward or equivalent f) Thermometer . – calibrated range to include 100 ± 1°C range g) Incubators . – capable of maintaining 37 ± 1°C

AOAC Research Institute Expert Review Panel Use Only

h) Dry double block heater unit. – capable of maintaining 100 ± 1°C; or a water bath

capable of maintaining 100 ± 1°C

i) Freezer . – capable of maintaining -10 to -20°C, for storing the 3M Molecular Detection

Chill Block Tray

j) Refrigerator . – capable of maintaining 2-8°C, for storing the 3M MDA2 k) Computer . – compatible with the 3M Molecular Detection System (instrument)

Safety Precautions

The user should read, understand and follow all safety information in the instructions for the 3M Molecular Detection System and the 3M Molecular Detection Assay 2 – Listeriamonocytogenes .

Retain the safety instructions for future reference.

04/05/2019